THE Food and Drug Administration (FDA) announced Thursday the voluntary recall of a particular batch of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) owing to its supposed failure to meet Good Manufacturing Practice (GMP).
According to FDA Advisory No. 2014-071, Novartis Healthcare Philippines Inc. ordered the recall of the product's Batch No. 420548 with Registration No. DR-X473.
This, it said, is in response to the statement of non-compliance with GMP that was issued by the Italian Medicines Agency (AIFA) to Societa ltaliana Medicinali Scandicci, srl. (SIMS), which is the manufacturer of the active pharmaceutical ingredient, Tetryzoline Hydrochloride.
Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) Ophthalmic Solution (Drops) is being used for the treatment of irritant conjunctivitis, allergic inflammatory conditions of the conjunctiva particularly hay fever conjunctivitis and vernal conjunctivitis.Hydrochloride was used in the manufacture of the specific batch of Spersallerg Ophthalmic Solution (Drops)," said the FDA.
Failing to meet the GMP, the FDA said, may pose threats to consumers, thus making a recall order necessary.
"The affected product presents safety risk and potential adverse health consequences," said the FDA.
With the recall order, all distributors, retailers. hospitals, pharmacies, or clinics that have the affected batches of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) are instructed to discontinue further distribution, sale and use.
Similarly, all field FDA Regulation Officers have been ordered to monitor the availability of the product batches in the market.
The product, the FDA noted, is packed in a LDPE Transparent Bottle containing l0 ml solution (box of 1's).